Quality

Our team of consultants understand the process within medical device manufacturers, whether the product is hardware, software or diagnostics.

From building quality processes in production locations, establishing new CAPA and auditing systems to Vigilance activities, we spend our working days understanding the role of Quality professionals from start-ups with 10 people to the global players with 15,000+ employees.

Quality Management/Quality Assurance
No two roles in quality management are the same, and we know that each company has it's own challenges, projects and development plans that the QM function will bring to life.

Our network is built strongly on the foundation of knowing ISO 13485 and the documentation required for compliance, and from there understanding your focus in the device lifecycle.

Whether you are working broadly across the QM/RA topics or responsible for medical safety and CAPA - we have seen it all and want to hear about your challenges and aspirations.

CAPA and Validation
​From building new CAPA systems to be compliant with the MDR or establishing a risk management reporting structure compliant to ISO 14971, we know the challenges and project focusses going through the medical device industry at any one time

​Looking at manufacturing process validation and CSV, our network has technical expertise to comply with the quality standards requirements.

PMS and Vigilance
Medical device safety is always at the top of everyone's mind in this industry. Our consultants are constantly updating their knowledge with regards to post-market surveillance requirements, PMS and PSUR reporting.

We have supported candidates to be successful in roles where safety forms part of a broader role, or for larger medical companies who need a dedicated safety professional responsible for a proactive and comprehensive vigilance system.

Auditing and Supplier Quality Assurance
Whether you are looking after the devices during production in QA, responsible for MDSAP implementation or visiting suppliers to ensure they are adhering your company quality assurance agreements, our consultants have covered roles all fields.

We understand the importance of strong negotiation, communication and stakeholder management skills to drive the relationship forward a smooth, compliant route to market.

Watch our video to learn about our recruitment expertise in Quality

 

Active jobs

Risk Manager

Munich
Germany
65,000EUR - 75,000EUR
Are you interested in joining a dynamic company who are innovating in the cardiovascular field? Would you like to have a major impact on the successful market delivery of medical devices and transform treatment options for patients? We're currently supporting a client in the medical device industry who are headquartered in Munich and are looking to strengthen their team. Responsibilities: Initiate, maintain, and update the risk management process in compliance with ISO 14971, 21 CFR820, and other relevant standards. Develop, maintain, and update all documents within the risk management file, including risk management plans, FMEAs, annual reports, and more. Coordinate and oversee all risk management activities with cross-functional teams.. Contribute to the assessment of customer feedback and risk evaluation, analysing quality issues, complaints, incidents, and proposed changes related to known and potential new risks. Prepare all risk-related documents for the technical file, such as risk-benefit analyses. Support and plan product Design Verification and Validation activities. Requirements and Skills: Bachelor’s degree in Engineering or a related field. 3+ years of experience in risk management of medical devices in accordance with ISO 14971, ideally for class II or III devices. Proficiency in technical, regulatory, and medical writing, with experience in drafting technical reports.  Fluency in English, German is a bonus. Experience working with regulatory bodies and competent authorities. Basic understanding of regulatory requirements for medical devices, particularly MDR and 21 CFR820. If you're interested in this position, please apply here and/or contact Hollie Dear at Adaptive Life Science for more information. #LI-HB1  #LI-Hybrid  

Quality Control Manager

Leipzig
Germany
€60,000 - €65,000 DOE
Quality Control Manager  Are you passionate about maintaining the highest standards of quality in medical device manufacturing and eager for the next step in your career? Our client, based in Saxony, is currently seeking a Quality Control Manager to join their team. Specializing in regenerative medicine and cutting-edge technology, our client excels in developing innovative products. As their Quality Control Manager, you will play a vital role in ensuring their innovative products meet quality standards.   Responsibilities: Establish quality procedures, standards, and specifications. Collaborate with purchasing manager to ensure raw materials meet quality requirements. Assess company production processes to develop in-house quality policies and procedures. Ensure compliance with local and global production standards. Implement and monitor quality assurance standards. Oversee product-related projects with subcontractors and internal departments and monitor product development processes.  Handle post-process activities such as sterilization, packaging, and shipment. Requirements: Bachelor of Science or similar education with minimum of 2 years of experience. Technical training or studies, ideally in quality or measurement. Analytical thinking and independent working style. Proficient in Q methods and tools, Microsoft 365 (especially Excel). High commitment and willingness to learn. Fluent in German and English with strong communication skills. If this sounds like you, please do not hesitate and send the application. If you have any questions regarding the position, please contact:  Dominika Wyrwinska at dominika.wyrwinska@adaptivelifescience.com #LI-DW1 #LI-Hybrid  

Regulatory Affairs Manager

Tuttlingen
Germany
60,000EUR - 70,000EUR
Regulatory Affairs Officer Overview Are you looking for a new challenge in regulatory affairs? I am currently supporting a client who specializes in sleep diagnostics in southern Germany in hiring an expert in EU MDR, approval processes, IEC 60601, IEC 62304 and ISO 14971. This is a hybrid working position where you can work 2/3 days from home. Tasks Implementation and maintenance of regulatory approval of medical devices in accordance with EU MDR Assisting in the compilation of documentation and supporting in the creation and maintenance of risk management files in accordance with ISO 14971 and usability files in accordance with IEC 62366-1 Support international distributors in the approval process of the medical devices PMS activities such as PMS files and vigilance investigations Your profile Experience in areas such as regulatory affairs or technical documentation in the MedTech or medical device industry Solid foundational knowledge of relevant regulatory and normative requirements (MDD, MDR, ISO 13485 etc.) IT Skills such as MS Office Good communication and organizational skills as well as independence and reliability Fluency in English and German Please apply with your CV or contact May-Lynn Capocciama-Knecht for further details on this opportunity and additional vacancies in R&D, Regulatory Affairs and Quality Management. may-lynn.ck@adaptivelifescience.com +49 30 1663 7750 #LI-MC2  

Senior Vigilance and PMS Specialist

Munich
Germany
70,000EUR - 85,000EUR
Senior PMS & Vigilance Specialist Are you a competitive spirit, looking for the next challenge to conquer? Do you believe that effective teamwork can propel you further than you could ever go by yourself? Are you looking for a future-proof workplace where personal and appreciative cooperation is at the core of your employer’s mission? Look no further… Overview: My client is an industry leader in orthopaedic product development and medical education. They are dedicated to delivering top-quality solutions for healthcare professionals and the countless patients benefiting from their devices. Tasks: Creation and submission of vigilance reports in the EMEA region Assessment of potentially reportable incidents Processing product complaints, monitoring and coordinating further processes Handling FSCAs Participating in internal and external audits Your Profile: Degree in a scientific, medical or technical field or comparable qualification Experience working with medical devices or similarly regulated products Sound knowledge of handling customer complaints and reportable events per MDR Knowledge of additional international medical device regulatory frameworks are a plus! (e.g. FDA, MDSAP etc.) Fluent written and spoken German and English are a must! Interested?  Please apply with your CV or contact Vivien Zsuzsanna Urban for further details on this opportunity and additional vacancies in R&D, Regulatory Affairs and Quality Management. vivien.urban@adaptivelifescience.com +49 30 16639819 #LI-VU1  

Field Service Engineer Wuerzburg

Wuerzburg
Germany
Flexible, depending on experience
Field Service Engineer Our esteemed client, a leading provider in the healthcare industry is currently seeking a talented individual to support clients in the Würzburg area. As part of their commitment to revolutionizing oncology solutions, they are currently looking for a dynamic full-time Field Service Engineer. In this role, you will play a pivotal role in ensuring the optimal performance of advanced medical equipment at clinics and private practices. Tasks: Act as the primary point of contact for customers (clinics and private practices) regarding service and repairs Perform upgrades, and procure necessary spare parts, with autonomous assignment planning Establish close communication with clinic and practice staff to identify errors, provide advice, and conduct equipment instruction Utilize software analysis tools to evaluate machine data and generate comprehensive service reports and documentation Requirements: Completed technician training or relevant studies with a technical emphasis (e.g., electrical or medical technology) Preferably, experience in the maintenance and repair of electronic devices Strong interpersonal skills and a dependable work ethic, with a passion for direct customer interaction Willingness to travel regularly in the Würzburg area Fluent in German and English, with a valid driver's license Benefits: 32 days of annual leave Company car provided for both business and personal use Attractive overtime and bonus arrangements Comprehensive company pension scheme Additional travel and accident insurance coverage at home and abroad Flexible working hours, comprising approximately 80% travel within the region and 20% home office Extensive bonuses for exceptional performance, along with subsidies for remote work Fitness club subsidies and the opportunity to lease a JobRad If you are passionate about making a difference in the fight against cancer and possess the skills and dedication required for this role, apply today and become part of a team committed to creating a world without fear of cancer. If you have any questions regarding the position, please contact: Dominika Wyrwinska at dominika.wyrwinska@adaptivelifescience.com #LI-DW1 #LI-Hybrid

Production & Supply Chain Manager

Dresden
Germany
70,000EUR - 90,000EUR
Production & Supply Chain Manager (m/w/d) Salary: €70,000 - €90,000 DOE Location: Dresden, Saxony, Germany (Hybrid) Our client is an innovative MedTech startup. They are setting new standards in this field with their products, which are characterized by unique technology, electronics, software, and artificial intelligence. Their products are used directly by end customers/patients and they realize production and logistics through a partner network. For their team in Dresden, they are looking for a Production & Supply Chain Manager Tasks: Support in the transfer of development results to production Participation in the selection of our manufacturing and logistics partners Independent support of the manufacturing partners Optimizing manufacturing and logistics processes with manufacturing partners in terms of quality and costs Ensuring delivery capability in accordance with sales planning Participating in the definition of service processes and returns processing with the partners involved Your Profile: Sound technical training and practical experience in the field of electrical engineering/electronics/mechatronics and/or corresponding technical or industrial engineering studies Approx. 5 years of professional experience in the production area with independent implementation of production control in compliance with cost and quality specifications Strong teamwork and communication skills Willingness and ability to create (in the start-up sector) Open to new approaches Knowledge of the medical technology sector is an advantage Sound knowledge of English. Benefits: An exciting and varied working environment in a dynamic and agile team Creative freedom in an agile start-up environment with a pioneering high-tech medical product Flexible trust-based working hours and the option to work remotely A permanent full-time contract with remuneration in line with the market Professional and personal development opportunities For more information or to apply, please reach out to luke.fines@adaptivelifescience.com with a copy of your CV or alternatively call +49 30 1663 4514  

Project Manager for Medical Device Development

Schwerin
Germany
65,000EUR - 75,000EUR
Project Manager for Medical Device Development Are you an engineering professional with project management expertise and a desire to innovate in a dynamic work environment? Our client located in northern part of Germany is currently seeking a Project Manager to lead the development of respiratory devices, ensuring structured processes, collaboration, and adherence to international standards. Tasks: Leadership in project management for medical device development Execution of all phases in a defined and structured development process Active participation in risk management following ISO 14971 Collaboration with external development partners and customers Co-responsibility for product design, comprehensive testing, validation, and compliance with CE regulations and harmonized standards Preparation of technical documentation for international approvals What is required: Degree in engineering or equivalent In-depth technical understanding Previous experience working within Project Management in MedTech.  Proficiency in both written and spoken German and English What is offered: Flexible working hours and potential for remote work Engaging tasks in growing company and development opportunities Dynamic work environment with creative freedom Annual holiday entitlement of 30 days Attractive social benefits If this sounds like you, please do not hesitate and send the application. If you have any questions regarding the position, please contact:  Dominika Wyrwinska at dominika.wyrwinska@adaptivelifescience.com #LI-DW1 #LI-Hybrid  

QM/QA Specialist

Stuttgart
Germany
50,000EUR - 60,000EUR
QM/QA Specialist Overview Our client has been developing and manufacturing implants, abutments and other components for suppliers for more than 25 years. Are you a working student or intern graduating this year and wanting to take your first step in Quality Management in the medical device industry? This is your chance! Tasks Maintenance and development of the quality management system in accordance with ISO 13485 Documentation management including risk management FMEA SOPs and trainings Process validation and monitoring Supplier management Complaint handling and CAPA management   Your profile Technical background with experience in Quality Management, Quality Assurance, CAPA or Risk Management in the medical device industry Familiarity with Norms and Standards like ISO 13485 Fluent in German and English Please apply with your CV or contact May-Lynn Capocciama-Knecht for further details on this opportunity and additional vacancies in Regulatory Affairs and Quality Management. may-lynn.ck@adaptivelifescience.com +49 30 1663 7750 #LI-MC2  

Read our Blogs

25. 05. 2023

Relocation – why it can come with benefits and growth when it’s done right

Relocation and its benefits are a huge topic within recruitment, especially when speaking about niche industries like: MedTech, Aviation and Aerospace, or Mining.
01. 02. 2023

Sustainability in MedTech & Life

Sustainability is more than a buzzword; it’s a business imperative. The world is facing environmental and social crises and consumers are demanding that companies and individuals take responsibility and action. It’s a hot topic in our work lives as much as it is privately. For many of us, it guides the brands we choose, the food we eat, and the decisions we make in day-to-day life. Fast fashion is one example of unsustainable living and a major contributor to the worldwide problem. Overall, the fashion industry is responsible for 8-10% of global emissions, according to the UN - more than the aviation and shipping combined. The term ‘fast fashion’ describes the quick turnover of fashion trends and the move towards cheap, mass-produced clothing where new lines are constantly released. What is the environmental impact of this? Most of fashion's environmental impact comes from the use of raw materials: ​Cotton for the fashion industry uses about 2.5% of the world's farmlandSynthetic materials like polyester require an estimated 342 million barrels of oil every yearClothes production processes such as dying requires 43 million tonnes of chemicals a year​How does sustainability impact the Medical Device industry? Manufacturers are giving sustainability in medical device design more and more attention. Sustainable medical equipment can benefit businesses in terms of cost savings, investor attraction, greater brand value, and competitive advantage, in addition to being better for the environment and appealing to consumers. Manufacturers must consider sustainability at the beginning of the design phase and take the equipment's whole lifecycle into account if they are to gain these advantages. How to make medical devices more sustainable There are many approaches to make medical devices more sustainable. For example, they could use less energy, be produced with low-emission materials and procedures, utilize fewer materials or less packaging, or have longer lifespans. The sustainability of a medical device is significantly influenced by the choice of materials. Using more sustainable materials makes a device more tolerable for patients, for example by using fewer toxic chemicals during production. Using the fewest resources possible in production helps to enable recycling alternatives. Sustainability considerations should be built into the design of the device from the very beginning. However, medical device manufacturers face several challenges as a result. A lot of devices, such as needles and catheters, must be packaged sterile, which produces a lot of waste. The options for substituting or reducing the materials used is often limited due to the sterility requirements. Other manufacturers can switch to reusable materials or make their packaging as mono-material a possible, which makes it easier to recycle. The first step in becoming more sustainable is having an awareness of it as a business, or as a personal goal. Using this awareness can help us all to make better conscious decisions in our buying patterns, and in our R&D processes.
10. 02. 2022

How to bounce back

I want to talk about criticism at work, how to take it, learn from it and move on.It is one of those factors, that un-FORTUNATELY (yes- you read it right) is ever present in our professional lives, and I for one am happy about that.However good we are at our jobs, however efficient and hard-working, there’s always room for improvement.… But how could we improve if we don’t think we need to?Just like Winston Churchill once said:“Criticism may not be agreeable, but it is necessary. It fulfills the same function as pain in the human body. It calls attention to an unhealthy state of things”Even though we all know that constructive criticism is more useful than a praise, I’m sure some of you would agree that being on the receiving end is not always easy.To help, I’ve put together a few tips:First, be open minded. Show your supervisor that you are open to receiving the feedback, why? Managers as well as clients also dislike giving criticism, so by saying that you are open to it, you prove your mental maturity and help to build a better rapport with them for future.Second, listen. Take it all in. Do not feel like you have to respond immediately. You want to show that you have listened, are not defensive and are accountable. Make sure to thank them for the feedback and let them know you appreciate it.Afterwards we might feel bad, embarrassed or even angry. That’s absolutely fine – we’re only human. Call your partner, friend or a close colleague and acknowledge your feelings. Then once you settle down you will start to see the situation in a new light.Third, learn. Try and find a lesson in the criticism given. Now that you had time to digest what’s been said, see what you can take from it for future improvements. 8 out of 10 times, negative feedback is given in order to help you develop and grow.Fourth, move on. Nothing more, nothing less. Once you’ve been given the feedback, you acknowledged your learning or reflected on the mistake – move on.The reason for giving you this feedback in the first place was not to put you down and make you feel incompetent – it is to ensure, that you improve and grow!